FDA Inspection
Dentium Co., Ltd.Dentium Co., Ltd. – FDA Inspection, Apr 17, 2014
Record Details
This FDA Inspection record concerns Dentium Co., Ltd., with an inspection on April 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dentium Co., Ltd.
- Inspection Date
- April 17, 2014
- Product Type
- Devices
View Company Profile
ID · d8125d81-1804-409e-9c7c-b169468b41f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 877464
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Dentium Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dentium Co., Ltd.
- FDA Inspection 667527 - 2010-03-11
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